43473-015 Genuine First Aid Antiseptic Pain Relieving

43473-015 Genuine First Aid Antiseptic Pain Relieving
SPL v1
SPL
SPL Set ID bc7c6739-6068-4694-adc9-0c0c5c347df4
Route
TOPICAL
Published
Effective Date 2023-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g) Lidocaine (0.5 g)
Inactive Ingredients
Aloe Glyceryl Stearate/peg-100 Stearate Mineral Oil Phenoxyethanol Stearic Acid Water Glycerin Propylene Glycol Disodium Hedta Ethylhexylglycerin Triclosan Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-19

Description

Active ingredient Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Indications and Usage

Uses

Temporary relief of pain assocoated with minor cuts, scrapes, and burns.

Helps protect against harmful bacteria

Dosage and Administration

Directions 

Clean affected area

Apply small amount not more than 3 times daily

Maybe covered with a sterile bandage

Description

Active ingredient Benzalkonium Chloride 0.13% Lidocaine HCL 0.5%

Section 44425-7

Other information

Store in a cool area 15C to 25C (59F to 77F)

Temper evident sealed packats

Do not use any opened or torn packets

Section 50565-1

Keep out of reach of  children. If swallowed, get medical help or contact a Poison Control Center directly.

Section 51727-6

Inactive ingredients

Aloe barbadensis leaf jiuce, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate/ PEG-100 Stearate, Glycerin, Maltodextrin, Mineral oil, Phenoxyethanol,  Propylene glycol, Water, Stearic acid, Triethanolamine

Section 51945-4

Section 55105-1

Purpose

First Aid Antiseptic

Topical Analgesic

Section 55106-9

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporary relief of pain assocoated with minor cuts, scrapes, and burns.

Helps protect against harmful bacteria

Dosage and Administration (34068-7)

Directions 

Clean affected area

Apply small amount not more than 3 times daily

Maybe covered with a sterile bandage

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor
Section 44425-7 (44425-7)

Other information

Store in a cool area 15C to 25C (59F to 77F)

Temper evident sealed packats

Do not use any opened or torn packets

Section 50565-1 (50565-1)

Keep out of reach of  children. If swallowed, get medical help or contact a Poison Control Center directly.

Section 51727-6 (51727-6)

Inactive ingredients

Aloe barbadensis leaf jiuce, Cetearyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate/ PEG-100 Stearate, Glycerin, Maltodextrin, Mineral oil, Phenoxyethanol,  Propylene glycol, Water, Stearic acid, Triethanolamine

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

First Aid Antiseptic

Topical Analgesic

Section 55106-9 (55106-9)

Active ingredient

Benzalkonium Chloride 0.13%

Lidocaine HCL 0.5%


Advanced Ingredient Data


Raw Label Data

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